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The Restore device is indicated for the prevention or decrease of episodes of urine leakage in women with stress incontinence.

Restore Female Continence device is a simple, noninvasive suction cup which fits over the urinary meatus. Air is squeezed out of the device's cap while it is positioned over the urinary meatus. When the cap is released, the device self-adheres to the anterior vaginal wall over the meatus via suction. If inadequate suction occurs. Aquaphor or a petroleum based ointment can be applied to the outside rim of the device to enhance suction. The suction or negative pressure created by the device causes coaptation and occlusion of the meatus and, therefore, increased urethral resistance. The amount of negative pressure generated by the device is optimized to counteract increases in intraabdominal and intravesical pressure during valsalva, thereby decreasing or preventing leakage.

Here's an analysis of the NEBL Restore Female Incontinence Device's acceptance criteria and the study used to prove it, based on the provided 510(k) summary:

Acceptance Criteria and Device Performance for NEBL Restore Female Incontinence Device

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) summary doesn't explicitly state pre-defined acceptance criteria with numerical targets in the same way a device specification document might. Instead, the "acceptance criteria" are implied by the clinical study's objectives: to demonstrate a statistically significant improvement in objective and subjective efficacy measures, and to show the device is safe and well-tolerated.

Here's a table summarizing the reported device performance against these implied criteria:

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: 100 women
• Data Provenance: The study was conducted in the U.S. across 8 Investigational Sites. It is a prospective clinical study as women used the device during a 12-week device usage period, with baseline (Control) measurements taken before device use and follow-up measurements at Week 12.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The document does not specify the number of experts used to establish the ground truth or their specific qualifications (e.g., "radiologist with 10 years of experience"). For objective tests like Pad Weight Test and Provocative Stress Test, the "ground truth" is inherently quantitative measurement. For subjective measures like the Incontinence Impact Questionnaire and Satisfaction Survey, the patients' own responses constitute the "ground truth." Clinical assessments (physical exams, urine cultures) would have been performed by medical professionals at the investigational sites, but their specific roles or the number involved in establishing a "ground truth" consensus are not detailed.

4. Adjudication Method for the Test Set

The document does not mention a specific adjudication method (e.g., 2+1, 3+1, none) for the test set. Given that the efficacy parameters were statistically analyzed using paired t-test, repeated-measures analysis, and Wilcoxon signed-rank testing, it implies direct measurement and patient reporting rather than a consensus-based adjudication process for the primary endpoints. Clinical safety assessments would have been part of standard clinical practice at each site.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The study described is a single-arm, pre-post comparison of device performance in a cohort of patients. It does not involve multiple human readers evaluating cases or comparing human performance with and without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This question is not applicable as the NEBL Restore device is a physical medical device (a suction cup) worn by patients, not an AI algorithm. Therefore, there is no "algorithm-only" performance to describe.

7. The Type of Ground Truth Used

The ground truth used for the test set was a combination of:

• Objective Measurements:
  • Pad Weight Test (PdWt): Direct measurement of urine leakage in grams.
  • Provocative Stress Test (PST): A score representing the severity of leakage during specific maneuvers.
  • Urine Cultures: Laboratory results for the presence of bacteriuria.
• Subjective Patient-Reported Outcomes:
  • Voiding Diary: Patient-reported number of incontinence episodes per day (IEPD).
  • Incontinence Impact Questionnaire (I-QOL): Patient-reported quality of life scores.
  • Satisfaction Survey: Patient-reported satisfaction with ease of placement/removal, performance, comfort, and tolerability (e.g., vaginal irritation).
• Clinical Observations:
  • Physical Examinations: Observations by medical professionals regarding adverse events.

8. The Sample Size for the Training Set

The document does not mention a "training set" in the context of device development. This term is primarily relevant for machine learning algorithms. For a physical medical device like the Restore, the "training" typically refers to engineering design iterations and perhaps pilot or feasibility studies. The clinical study of 100 women serves as the primary evaluation of the final device design.

9. How the Ground Truth for the Training Set Was Established

As there is no "training set" described for an AI algorithm, this question is not applicable. For the physical device, the "ground truth" during its development phases would have been established through a combination of engineering testing, user feedback on prototypes, and nonclinical studies (e.g., biocompatibility) to refine the design before formal clinical efficacy trials.

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The Restore Continence Device is an external female continence device indicated for the management of urinary leakage in women suffering from stress urinary incontinence. Although it can help control urinary incontinence, it will not correct the underlying cause of the condition.

The Restore Female Continence device is a simple, non invasive suction cup device which fits over the urinary meatus. Similar to a suction cup, air is squeezed out of the device's cap while it is positioned over the urinary meatus. When the cap is released, the device self-adheres to the anterior vaginal wall over the meatus via self-suction. If inadequate suction occurs, Aquaphor or an equivalent ointment can be applied to the outside rim of the device to enhance adhesion. The suction or negative pressure created by the device causes coaptation and occlusion of the meatus and therefore, increased urethral resistance. The amount of negative pressure generated by the device is optimized to counteract increases in intra-abdominal and intravesical pressure during valsalva thereby decreasing or preventing leakage.

The NEBL Restore Female Continence Cap is a device designed to manage urinary leakage in women suffering from stress urinary incontinence.

Here's an analysis of its acceptance criteria and the study conducted:

1. Table of Acceptance Criteria and Reported Device Performance:

Note: The document does not explicitly state pre-defined acceptance criteria values in the way a modern regulatory submission might. Instead, it presents baseline (Control) measurements and then demonstrates statistically significant improvement in the device utilization period. The "acceptance criteria" here are interpreted as the baseline performance levels that the device aims to significantly improve upon.

2. Sample Size Used for the Test Set and Data Provenance:

• Sample Size: 100 women.
• Data Provenance: The study was conducted at "Investigational Sites in the U.S." This indicates the data is from the United States and is prospective, as it involves the use of the device over a 12-week period.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:

The document does not specify the number of experts or their qualifications for establishing ground truth for the clinical tests (PdWt, PST, IEPD, I-QOL), as these are objective and subjective measurements rather than interpretations by experts.

4. Adjudication Method for the Test Set:

Not applicable, as the tests involve objective measurements (Pad Weight, Provocative Stress Test, Incontinence Episodes Per Day) or patient self-reporting (I-QOL, satisfaction surveys) rather than expert adjudication of qualitative data.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed. The study focuses on the device's effectiveness compared to a baseline (control) measurement in individual patients, not on comparing performance between human readers with and without AI assistance. The device itself is not an AI system.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

Yes, in a sense. The described efficacy tests (PdWt, PST, IEPD, I-QOL) measure the direct physical and perceived impact of the device on the patient's incontinence. There isn't an "algorithm" in the modern AI sense, but the device's physical mechanism of occlusion is being tested standalone without human intervention affecting its core function once applied. The study assesses the device's inherent ability to reduce or prevent incontinence.

7. Type of Ground Truth Used:

The ground truth for the clinical study was established using a combination of:

• Objective Measures:
  • Pad Weight Test (PdWt): A quantitative measure of urine leakage.
  • Provocative Stress Test (PST): A measure of leakage under stress conditions.
• Subjective Measures (Patient-Reported Outcomes):
  • Voiding Diary: Documenting the number of incontinence episodes per day (IEPD).
  • Incontinence Impact Questionnaire (I-QOL): Measuring the impact of incontinence on quality of life.
  • Satisfaction Survey: Evaluating aspects like function, comfort, and ease of use.
• Safety Data: Urine cultures (for bacteriuria), irritation questionnaires, and periodic physical examinations.

8. Sample Size for the Training Set:

Not applicable. The NEBL Restore Female Continence Cap is not an AI device that requires a training set. It is a physical medical device. The "training" in the context of this device refers to patients becoming more proficient with device placement, not an algorithmic training process.

9. How the Ground Truth for the Training Set Was Established:

Not applicable, as there is no training set for an AI algorithm.

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